On May 14, 2020 Flatiron Health reported eight abstracts were accepted for presentation at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program, to be held May 29–31 (Press release, Flatiron Health, MAY 14, 2020, View Source [SID1234558075]).

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"The research being presented displays the broad impact that real-world data derived from electronic health records has across the oncology therapeutic lifecycle from discovery through development and ultimately in support of patient care," said Dr. Michael Vasconcelles, chief medical officer at Flatiron. "It is a rich illustration of the knowledge that can be created when experts collaborate across the oncology ecosystem."

The key areas studied include:

Biomarkers that predict who may benefit from targeted treatments
Treatment patterns at the end of life
Barriers and solutions to clinical trial participation
Novel clinico-genomic research
Flatiron collaborated on the accepted research with: University of Pennsylvania, Yale Cancer Center, Florida Cancer Specialists, Hematology Oncology Associates of Central New York, Southeast Nebraska Cancer Center, Tennessee Oncology, West Cancer Center, Foundation Medicine, and Genentech, a member of the Roche Group.

Full abstracts will be posted at rwe.flatiron.com post-ASCO embargo on May 29.

Poster Presentations

PD-L1 tumor proportion score and clinical benefit from first-line pembrolizumab in patients with advanced nonsquamous versus squamous NSCLC

First Author: Deborah B. Doroshow, Icahn School of Medicine at Mount Sinai
Abstract: 9539
Poster: 305

Association of BRCA alteration (alt) type with real-world (RW) outcomes to PARP inhibitors (PARPi) in patients (pts) with metastatic castrate resistant prostate cancer (mCRPC)

First Author: Emmanuel S. Antonarakis, Sidney Kimmel Comprehensive Cancer Center
Abstract: 5527
Poster: 108

Use of real world data to understand barriers to interventional clinical trial enrollment in community oncology clinics (COC)

First Author: Johnetta Blakely, Tennessee Oncology
Abstract: 2061
Poster: 5

The adoption of immune checkpoint inhibitors and patterns of care at the end of life

First Author: Fauzia Riaz, Yale School of Medicine
Abstract: 12027
Poster: 315

A multi-stakeholder platform to prospectively link longitudinal real-world clinico-genomic; imaging; and outcomes data for patients with metastatic lung cancer

First Author: Michael W. Lu, Genentech
Abstract: TPS2087
Poster: 79

An automated EHR-based tool for identification of patients (pts) with metastatic disease to facilitate clinical trial patient ascertainment

First Author: Jeffrey J. Kirshner, Hematology Oncology Associates of Central New York
Abstract: 2051
Poster: 43

Characteristics and outcomes of real-world patients with microsatellite instability-high (MSI-H) solid tumors treated with pembrolizumab monotherapy after FDA approval

First Author: Tamara Snow, Flatiron Health
Abstract: 3060
Poster: 124

Real-world (RW) outcomes for advanced non-small cell lung cancer (aNSCLC) patients (pts) with EGFR exon 19 deletions (x19del) stratified by deletion size

First Author: Sai-Hong I. Ou, University of California Irvine Chao Comprehensive Cancer Center
Abstract: 9591
Poster: 357

On May 14, 2020 SkylineDx reported the publication of two ASCO (Free ASCO Whitepaper) abstracts describing a biomarker that identifies a subgroup of skin cancer (cutaneous melanoma) patients that could benefit from adjuvant therapy as their melanoma is at high risk of recurrence, but who are currently not diagnosed as high risk because they do not have metastasis in their sentinel lymph nodes (Press release, SkylineDx, MAY 14, 2020, View Source [SID1234558091]). At present only melanoma patients that have detected metastasis in their lymph nodes (clinical stage III) are referred for adjuvant therapy. In a US cohort totaling 837 patients, 637 (76%) patients had no nodal metastasis in which the biomarker (named the CP-GEP model) was able to identify 327 (51%) patients at high-risk of melanoma recurrence within 5 years. This group has a similar prognosis as the treatment eligible stage III patients [3].

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Clinical trials on adjuvant treatment are moving towards the inclusion of non-metastatic stage IIB and IIC patients. Nonetheless, a stage-specific optimization of the CP-GEP model identified an additional 45% of stage IIA patients in the above-mentioned cohort, currently excluded from trials, with a demonstrated worse prognosis than stage IIC and IIIA patients. These patients should be considered for inclusion into a trial to investigate if treatment with adjuvant systemic therapy can prevent their melanoma from returning [4]. The optimized CP-GEP model for this prognostic utility will be further researched under the Peregrine Study Initiative in the Falcon R&D Program.

Melanoma specialist, Dr. Alexander Eggermont, Chief Scientific Officer of the Princess Máxima Center in the Netherlands, says: "Over the last years significant progress has been made in advancing adjuvant treatments for metastatic stage III melanoma patients. However, large population-based studies demonstrate that approximately 50% of melanoma-related deaths occur in patients that were originally diagnosed with non-metastatic disease. The discovery of the prognostic CP-GEP model to select high-risk Stage IIA patients for adjuvant therapy is a significant breakthrough that can potentially benefit thousands of patients annually."

"One of our core value statements is to think about how our innovation can impact many lives", comments Dharminder Chahal, CEO SkylineDx. "It is confronting to see the potential undertreatment in these skin cancer patients. Some are going home, partially reassured of not having metastasis, only to find out later that the melanoma has returned relatively fast. There should be a research focus on the improvement we could achieve in defining personalized treatment pathways on the basis of individual risk."

About CP-GEP

The CP-GEP model calculates the risk of melanoma returning on an individual basis through a combination analysis of 8 genes from the patient’s primary tumor, the tumor thickness and the patient’s age. The model has been previously published in JCO Precision Oncology [2].The prognostic use of the CP-GEP model is the main focus of the Peregrine Study Initiative, developed under the wings of the Falcon R&D Program. More information on www.falconprogram.com.

On May 14, 2020 Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSXV:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, reported that it has commenced an overnight marketed public offering (the "Offering") of units (the "Units") of the Company (Press release, Tetra Bio Pharma, MAY 14, 2020, View Source [SID1234561072]). Each Unit is offered at a price of $0.26 per Unit (the "Issue Price") with each Unit consisting of one common share in the capital of Tetra (a "Common Share") and one common share purchase warrant (a "Warrant"). Each Warrant will entitle the holder thereof to acquire one Common Share at a price of $0.32 for a period of 36 months from the closing date of the Offering.

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The Offering will be conducted on a best efforts agency basis pursuant to the terms and conditions of an agency agreement to be entered into between the Company and Raymond James Ltd. and Canaccord Genuity Corp. as co-lead agents and joint bookrunners (collectively, the "Agents").

The size of the Offering will be determined in the context of the market at the time of entering into a definitive agency agreement between the Company and the Agents. The Company will also grant the Agents an option (the "Over-Allotment Option") to sell up to an additional 15% of the Units sold under the Offering, at the Issue Price. The Over-Allotment Option may be exercised in whole or in part to purchase Common Shares, Warrants or Units as determined by the Agents upon written notice to the Company at any time up to 30 days following the closing date of the Offering.

The Offering will be conducted pursuant to the Company’s Canadian base shelf prospectus dated April 1, 2020 (the "Base Shelf Prospectus"). A prospectus supplement (the "Prospectus Supplement") relating to the Offering will be filed in each of the provinces of Canada. Copies of the Prospectus Supplement and accompanying Base Shelf Prospectus will be available under the Company’s profile on SEDAR at www.sedar.com.

The Company intends to use the net proceeds of the Offering to continue the development of its clinical program, including Phase 2 and phase 3 clinical trials, toxicology, regulatory and manufacturing expenses related to QIXLEEF (PPP001).

The Offering is expected to close on or about May 22, 2020, subject to customary closing conditions.

Closing of the Offering is subject to certain conditions including, but not limited to, the receipt of all necessary approvals including the approval of the TSX Venture Exchange.

On May 14, 2020 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that data collected from the Company’s development program of docecal, a solvent-free nanoparticle micellar formulation of docetaxel have been accepted for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Annual meeting taking place between May 29 -June 02, 2020 (Press release, Oasmia, MAY 14, 2020, View Source [SID1234557965]).

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The poster, entitled; "Pharmacokinetics, safety and early activity of a nanoparticle micellar formulation of docetaxel in women with metastatic breast cancer: Results of two randomized trials (phase I and II)" will be presented by Dr Markus Joerger, MD, PhD, Cantonal Hospital, St. Gallen, Switzerland at the session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology. The phase I study was performed to determine the pharmacokinetics of docetaxel micellar in 30 patients and the phase II study was a randomized active-controlled study where 200 patients were treated. The bioequivalence of docetaxel micellar to docetaxel and the improved safety profile will be presented and discussed in relation to the future development program of the product.

"We are pleased to present and discuss this important research, which highlights results from our pipeline. Our clinical program continues to advance our XR17 technology platform," says Dr. Reinhard Koenig, Acting Chief Medical Officer at Oasmia Pharmaceutical.

ASCO is an organization for clinical oncologists and provides recommendations for clinical practices and publishes the scientific journal Journal of Clinical Oncology among other things. Due to public health safety concerns related to COVID-19, this year’s meeting will be a global virtual event held during the dates of the originally planned in-person Annual meeting.

On May 14, 2020 Genmab A/S (Nasdaq: GMAB) reported that eight industry sponsored abstracts regarding Genmab and partner programs were accepted for presentation at the 25th European Hematology Association (EHA) (Free EHA Whitepaper) EHA (Free EHA Whitepaper)25 Virtual Congress 2020, taking place virtually on June 11-14, 2020 (Press release, Genmab, MAY 14, 2020, View Source [SID1234557998]). A list of accepted Industry-sponsored abstracts featured at the congress includes two abstracts on epcoritamab (DuoBody-CD3xCD20), one on HexaBody-CD38, one on DuoHexaBody-CD37 and four daratumumab abstracts. The abstracts have been published on the EHA (Free EHA Whitepaper) website and may be accessed via www.ehaweb.org. All e-Poster presentations will be made available on the on-demand Virtual Congress platform Friday, June 12 at 08:30 CEST.

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"We are very pleased to see that once again a broad spectrum of data from Genmab’s innovative clinical and pre-clinical proprietary pipeline has been accepted for presentation at the prestigious EHA (Free EHA Whitepaper) Congress," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Industry-Sponsored Abstracts are as follows:

Epcoritamab (DuoBody-CD3xCD20):
Subcutaneous epcoritamab (DuoBody-CD3×CD20) induces complete response in heavily pre-treated patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma: Phase 1/2 dose escalation

Evaluation of pharmacodynamic biomarkers of epcoritamab (GEN3013; CD3CD20): Results from a Phase 1/2 dose-escalation study in relapsed/refractory B-cell Non-Hodgkin Lymphoma

HexaBody-CD38:
Superior anti-tumor activity of HexaBody-CD38 in preclinical models of Multiple Myeloma, B Cell Lymphoma and AML

DuoHexaBody-CD37:
DuoHexaBody-CD37 shows potent anti-tumor activity in pre-clinical B-cell lymphoma models in vitro and in vivo

Daratumumab (Submitted by Janssen Biotech, Inc.):
Phase 3 Study of Daratumumab/Bortezomib/Dexamethasone Versus Bortezomib/Dexamethasone in Chinese Patients with Relapsed/Refractory Multiple Myeloma: MMY3009 (LEPUS)

Corticosteriod Tapering in Patients with Relapsed or Refractory Multiple Myeloma Receiving Subcutaneous Daratumumab: Part 3 of the Open-label, Multicenter, Phase 1b PAVO Study

Impact of Depth of Response and Minimal Residual Disease on Health-Related Quality of Life of Transplant-Ineligible Patients with Newly-Diagnosed Multiple Myeloma

Daratumumab + Bortezomib, Thalidomide, and Dexamethasone in Transplant-eligible Newly Diagnosed Multiple Myeloma: Baseline slimCRAB-based Subgroup Analysis of CASSIOPEIA